Data / Medical devices / United States / Fischer Medical
Fischer Medical: FDA-registered device maker in Wheat Ridge, CO, United States, 2 510(k) clearances
Fischer Medical is registered with the FDA (registration 3006188092) in Wheat Ridge, CO, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 29, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006188092
- Address
- 3990 Youngfield Street, Wheat Ridge, CO, United States, 80033
- Owner or operator
- FISCHER MEDICAL (9099682)
- Roles
- Manufacturer, Remanufacturer
- First device listed
- March 28, 2007
- Registered through
- 2026
- Brand names listed
- BLOOM DTU ELECTROPHYS. PROG. STIMU, Bloom 2, EPSTIM SOFTWARE, Hotchkiss, LATOR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | JOQ | 2 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Manufacturer, Remanufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 29, 2018 | K173439 | Bloom2 Programmable Electrophysiology Stimulator | JOQ | Substantially Equivalent | Fischer Medical | accessdata.fda.gov |
| May 5, 2000 | K991293 | EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR | JOQ | Substantially Equivalent | Fischer Medical Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Otoscope
- All makers of Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Updated March 29, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.